Summary

#LI-Onsite

This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality Control professionals to help us reach our ambitious goals.

The Production Manager is responsible for overseeing the daily production process, coordinating all production activities and operations. Monitor the production processes and adjusts schedules as needed. Monitor productivity rates and product standards implement process improvement programs.

• Responsible for the daily operations and efficient utilization of resources to meet processing demands.
• Ensure the products are produced, inspected, stored and released in accordance with approved procedures.
• Support shop floor trouble shooting and problem solving as needed.
• Responsible for authoring, reviewing and/or approving GMP documents including but not limited to SOPs, Batch Records, Labels, Protocols, Reports, Validation documents.
• Ensure Good Documentation Practice are followed on the shop floor.
• Ensure production team receives complete cGMP training and are qualified to perform the required operations.
• Support compliance activities including deviations, CAPAs, Investigation and OOS and OOT
• Interview and hire production staff in conjunction with Production Support Leads and/or Head of Production.
• Implement cost control programs or procedures.
• Audit and review emergency paperwork and processes to ensure compliance.
• Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demands.
• Support a culture of safety, diversity and inclusion.

• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry preferred.
• 4+ years' experience in Aseptic/GMP manufacturing process support role in the pharmaceutical industry, experience with radiopharmaceuticals is preferred.
• Good understanding or capacity to quickly understand production processes, scientific & technical (automation) understanding.
• Change management, adaptability, ability to work under pressure.
• Excellent organizational and time-management abilities.